US20200196918A1 - Device, system and method for non-invasive monitoring of physiological measurements - Google Patents

Device, system and method for non-invasive monitoring of physiological measurements Download PDF

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Publication number
US20200196918A1
US20200196918A1 US16/612,383 US201816612383A US2020196918A1 US 20200196918 A1 US20200196918 A1 US 20200196918A1 US 201816612383 A US201816612383 A US 201816612383A US 2020196918 A1 US2020196918 A1 US 2020196918A1
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light
scattered
sensors
sensor
subject
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Moti Itzkovich
Ohad BASHAN
Giora BAR-SAKAI
Oded Bashan
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Wear2b Ltd
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Wear2b Ltd
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Assigned to Wear2B Ltd. reassignment Wear2B Ltd. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BAR-SAKAI, GIORA, BASHAN, ODED, BASHAN, Ohad, ITZKOVICH, MORDECHAI
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7221—Determining signal validity, reliability or quality
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Definitions

  • the present invention generally relates to non-invasive physiological measurements. More particularly, the present invention relates to wearable devices, systems and methods for non-invasive monitoring and analyzing of physiological measurements.
  • checks may include taking periodic (e.g., monthly, quarterly) blood tests to check cholesterol levels in the blood, or daily glucose tests with a dedicated device (typically requiring skin puncturing) so as to monitor the glucose levels in the blood.
  • NIRS near infra-red spectroscopy
  • a modified Beer-Lambert law can be applied to quantify changes in chromophore concentration as function of time (t) from the measured changes in tissue attenuation. This modified law uses the differential path length ⁇ L( ⁇ ,t)> which is defined as the local gradient of the attenuation versus the absorption coefficient of the tissue.
  • ⁇ L( ⁇ ,t)> is the average distance the detected light has traveled in the tissue. The farther the light is travel in the tissue the deeper its penetrates.
  • ⁇ L( ⁇ ,t)> is correlated to D—the depth from the skin surface)
  • ⁇ L( ⁇ ,t)> is affected by the changes in chromophore concentration as a function of time.
  • ⁇ ⁇ ⁇ OD ⁇ ( ⁇ , t ) - ln ⁇ ( I ⁇ ( ⁇ , t ) I 0 ⁇ ( ⁇ ) ) ⁇ ⁇ L ⁇ ( ⁇ , t ) > ⁇ a ⁇ ( ⁇ , t ) + ( ⁇ a 0 ⁇ ( ⁇ ) ⁇ s ′0 ⁇ ( ⁇ ) ) ⁇ L ⁇ ( ⁇ , t ) > ⁇ s ′ ⁇ ( ⁇ , t ) ( 1 )
  • ⁇ is the wavelength
  • ‘t’ is the time from detection start
  • I( ⁇ ,t) is the intensity detected at time ‘t’ in wavelength ‘ ⁇ ’
  • ⁇ L( ⁇ ,t)> is the differential path length that is approximately equal to the mean path length
  • ⁇ i ( ⁇ ) and C i (t) are the molar absorptivity and molar concentration of a component ‘i’ in the media, respectively.
  • the device may include at least one light source for emitting light at at least one predetermined narrow spectral wavelength band onto a living tissue of the subject and two or more light sensors (S 1 , . . . , S n ).
  • each of the two or more light sensors (S 1 , . . . , S n ) may correspond to a specific substance in a living tissue of the subject and is configured to measure a change in a concentration of the specific substances to which the sensor corresponds.
  • the maximal signal to noise ratio is the ratio between the intensity of light scattered by the specific substance and all other intensities received at the corresponding sensor.
  • the distance (d 1 , . . . , d n ) of each of the two or more sensors from the light source may further determined according to the depth a layer (L 1 , . . . , L n ) of the living tissue in which one or more of the substances is contained.
  • the distance (d 1 , . . . , d n ) of each of the two or more sensors from the light source is further determined using scattering and absorbing parameters of each substance.
  • the one or more narrow spectral wavelengths bands may be between 400-2500 nm and have a difference of 5-100 nm between the upper wavelength and the lower wavelength of each band.
  • the non-invasive monitoring device may include a wearable housing for holding the at least one light source and the two or more light sensors.
  • the non-invasive monitoring device may include a communication unit and a controller.
  • the controller may be configured to: receive measurements of scattered light intensities received at each of the two or more light sensors and send, via the communication unit, information to a computing device.
  • the controller may further be configured to control the at least one light source to emit light; receive measurements of scattered light intensities received at each of the two or more light sensors, at an initial time (t 0 ); receive measurements of scattered light intensities received at each of the two or more light sensors, at at least one consecutive time (t); and determine a change of a concentration in time, of at least one substance in the user's tissue based on the measured light intensities.
  • the controller may further be configured to: control the at least one light source to emit light at two or more predetermined narrow spectral wavelength bands; receive measurements of scattered light intensities received at each of the two or more light sensors at the two or more predetermined narrow spectral wavelength bands, at an initial time (t 0 ); receive measurements of scattered light intensities received at each of the two or more light sensors at two or more predetermined narrow spectral wavelength bands, at at least one consecutive time (t); and determine a change of a concentration in time, of one or more substances in the user's tissue based on the measured light intensities.
  • the system may include at least one non-invasive monitoring device according to any one of the embodiments disclosed herein and a computing device configured to: receive measurements of scattered light intensities received at each of the two or more light sensors and send, via the communication unit, information to a computing device.
  • the controller may further be configured to control the at least one light source to emit light; receive measurements of scattered light intensities received at each of the two or more light sensors, at an initial time (t 0 ); receive measurements of scattered light intensities received at each of the two or more light sensors, at at least one consecutive time (t); and determine a change of a concentration in time, of at least one substance in the user's tissue based on the measured light intensities.
  • the controller of the a computing device may further be configured to: control the at least one light source to emit light at two or more predetermined narrow spectral wavelength bands; receive measurements of scattered light intensities received at each of the two or more light sensors at the two or more predetermined narrow spectral wavelength bands, at an initial time (t 0 ); receive measurements of scattered light intensities received at each of the two or more light sensors at two or more predetermined narrow spectral wavelength bands, at at least one consecutive time (t); and determine a change of a concentration in time, of one or more substances in the user's tissue based on the measured light intensities.
  • the method may include emitting light from a light source having at least one predetermined narrow spectral wavelengths band; measuring scattered light intensities received at each of two or more light sensors, at an initial time (t 0 ); measuring scattered light intensities received at each of the two or more light sensors, at at least one consecutive time (t); and determining a change of a concentration in time, of at least one substance in a user's tissue based on the measured light intensities.
  • each of the two or more light sensors (S 1 , . . .
  • the distance (d 1 , . . . , d n ) of each of the two or more sensors from the light source may be determined so that intensity (I 1 , . . . , I n ) of light scattered by each specific substance, may have a maximal signal to noise ratio at the determined distance of the corresponding sensor.
  • the maximal signal to noise ratio is the ratio between the intensity of light scattered by the specific substance and all other intensities received at the corresponding sensor.
  • the method may further include: controlling the at least one light source to emit light at two or more predetermined narrow spectral wavelength bands; receiving measurements of scattered light intensities received at each of the two or more light sensors at the two or more predetermined narrow spectral wavelength bands, at an initial time (t 0 ); receiving measurements of scattered light intensities received at each of the two or more light sensors at two or more predetermined narrow spectral wavelength bands, at at least one consecutive time (t); and determining a change of a concentration in time, of one or more substances in the user's tissue based on the measured light intensities.
  • the device may include two or more light sources (l 1 , . . . , l n ) for emitting light at at least one predetermined narrow spectral wavelength band onto a living tissue of the subject and one light sensor (S).
  • each of the two or more light sources may correspond to a specific substance in a living tissue of the subject; and the one light sensor may be configured to measure a change in a concentration of the specific substances to which the light source corresponds.
  • the distance (d 1 , . . . , d n ) of each of the two or more light sources from the light sensor is further determined according to the depth a layer (L 1 , . . . , L n ) of the living tissue in which one or more of the substances is contained.
  • the non-invasive monitoring device may further include a communication unit and a controller configured to receive measurements of scattered light intensities received at the light sensor; and send, via the communication unit, information to a computing device.
  • the controller may further be configured to: control the two or more light sources to emit light; receive measurements of scattered light intensities received the light sensor, at an initial time (t 0 ); receive measurements of scattered light intensities received the light sensor, at at least one consecutive time (t); and determine a change of a concentration in time, of at least one substance in the user's tissue based on the measured light intensities.
  • the controller may further be configured to: control the two or more light sources to emit light at two or more predetermined narrow spectral wavelength bands; receive measurements of scattered light intensities at the light sensor at the two or more predetermined narrow spectral wavelength bands, at an initial time (t 0 ); receive measurements of scattered light intensities at the light sensor at two or more predetermined narrow spectral wavelength bands, at at least one consecutive time (t); and determine a change of a concentration in time, of one or more substances in the user's tissue based on the measured light intensities.
  • the system may include at least one non-invasive monitoring device according to any one of the embodiments discloses herein and a computing device configured to: control the two or more light sources to emit light; receive measurements of scattered light intensities received the light sensor, at an initial time (t 0 ); receive measurements of scattered light intensities received the light sensor, at at least one consecutive time (t); and determine a change of a concentration in time, of at least one substance in the user's tissue based on the measured light intensities.
  • the computing device may further be configured to: control the two or more light sources to emit light at two or more predetermined narrow spectral wavelength bands; receive measurements of scattered light intensities at the light sensor at the two or more predetermined narrow spectral wavelength bands, at an initial time (t 0 ); receive measurements of scattered light intensities at the light sensor at two or more predetermined narrow spectral wavelength bands, at at least one consecutive time (t); and determine a change of a concentration in time, of one or more substances in the user's tissue based on the measured light intensities.
  • the method may include: emitting light from two or more light sources having at least one predetermined narrow spectral wavelengths band; measuring scattered light intensities received at a light sensor, at an initial time (t 0 ); measuring scattered light intensities received at the light sensor, at at least one consecutive time (t); and determining a change of a concentration in time, of at least one substance in a user's tissue based on the measured light intensities.
  • each of the two or more light sources may correspond to a specific substance in a living tissue of the subject; and the one light sensor may be configured to measure a change in a concentration of the specific substances to which the light source corresponds.
  • the distance (d 1 , . . . , d n ) of each of the two or more light sources from the light sensor may be determined so that intensity (I 1 , . . . , I n ) of light scattered by each specific substance, has a maximal signal to noise ratio at the determined distance of the corresponding light source
  • the maximal signal to noise ratio is the ratio between the intensity of light scattered by the specific substance and all other intensities received at the corresponding sensor.
  • the method may further include: controlling the two or more light source to emit light at two or more predetermined narrow spectral wavelength bands; receiving measurements of scattered light intensities received at the light sensor at the two or more predetermined narrow spectral wavelength bands, at an initial time (t 0 ); receiving measurements of scattered light intensities received at the light sensor at two or more predetermined narrow spectral wavelength bands, at at least one consecutive time (t); and determining a change of a concentration in time, of one or more substances in the user's tissue based on the measured light intensities.
  • FIG. 1A shows a block diagram of an exemplary system for non-invasive monitoring of a physiological condition of a subject according to some embodiments of the present invention
  • FIG. 1B schematically illustrates a block diagram of the non-invasive monitoring system, according to some embodiments of the invention
  • FIGS. 2A and 2B schematically illustrate cross-sectional views of non-invasive monitoring devices for monitoring physiological condition of a subject according to some embodiments of the invention.
  • FIGS. 3A and 3B are flowcharts of methods of non-invasive monitoring of physiological condition of a subject, according to some embodiments of the invention.
  • the terms “plurality” and “a plurality” as used herein may include, for example, “multiple” or “two or more”.
  • the terms “plurality” or “a plurality” may be used throughout the specification to describe two or more components, devices, elements, units, parameters, or the like.
  • the term set when used herein may include one or more items.
  • the method embodiments described herein are not constrained to a particular order or sequence. Additionally, some of the described method embodiments or elements thereof can occur or be performed simultaneously, at the same point in time, or concurrently.
  • a wearable device having one or more light sources and one or more sensors may be placed to a skin of a subject to measure changes in concentration of one or more substances (e.g., glucose, a certain protein, etc.) in the subject's tissue (e.g., blood vessel).
  • one or more substances e.g., glucose, a certain protein, etc.
  • tissue e.g., blood vessel.
  • Light emitted from the one or more light sources onto the skin of the subject may be absorbed or penetrate and scattered from various layers of the skin.
  • the absorption and scattering property of each layer the may depend from the composition of the layer (the concentration of the one or more substances), since different substances have different absorption and scattering properties.
  • a device, system and method may detect light scattered from one or more layers of the skin to detect changes in the concentration of one or more substances over time.
  • the detected change may indicate a change in the physiological condition of the subject.
  • System 100 may include a computing device 11 and at least one non-invasive monitoring device 110 for monitoring of a physiological condition of a subject.
  • Computing device 11 may be in wired or wireless communication with non-invasive monitoring device 110 .
  • Computing device 11 may include a controller 15 that may be, for example, a central processing unit processor (CPU), a chip or any suitable computing or computational device, an operating system 16 , a memory 12 , a storage 17 , an input device 13 and an output device 14 .
  • a controller 15 may be, for example, a central processing unit processor (CPU), a chip or any suitable computing or computational device, an operating system 16 , a memory 12 , a storage 17 , an input device 13 and an output device 14 .
  • Operating system 16 may be or may include any code segment designed and/or configured to perform tasks involving coordination, scheduling, arbitration, supervising, controlling or otherwise managing operation of computing device 11 , for example, scheduling execution of programs. Operating system 16 may be a commercial operating system.
  • Memory 12 may be or may include, for example, a Random Access Memory (RAM), a read only memory (ROM), a Dynamic RAM (DRAM), a Synchronous DRAM (SD-RAM), a double data rate (DDR) memory chip, a Flash memory, a volatile memory, a non-volatile memory, a cache memory, a buffer, a short term memory unit, a long term memory unit, or other suitable memory units or storage units.
  • Memory 12 may be or may include a plurality of, possibly different memory units.
  • Executable code 18 may be any executable code, e.g., an application, a program, a process, task or script. Executable code 18 may be executed by controller 15 possibly under control of operating system 16 . Where applicable, executable code 18 may carry out operations described herein, possibly in real-time. Computing device 11 and executable code 18 may be configured to update, process and/or act upon information at the same rate the information, or a relevant event, are received. In some embodiments, more than one computing device 11 may be used. For example, a plurality of computing devices that include components similar to those included in computing device 11 may be connected to a network and used as a system.
  • Storage 17 may be or may include, for example, a hard disk drive, a universal serial bus (USB) device or other suitable removable and/or fixed storage unit. Content may be stored in storage 17 and may be loaded from storage 17 into memory 12 where it may be processed by controller 15 . In some embodiments, some of the components shown in FIG. 1A may be omitted.
  • memory 12 may be a non-volatile memory having the storage capacity of storage 17 . Accordingly, although shown as a separate component, storage 17 may be embedded or included in memory 12 .
  • Input devices 13 may be or may include a sensor, a keyboard, a touch screen or pad or any suitable input device. It will be recognized that any suitable number of input devices may be operatively connected to computing device 11 as shown by block 13 .
  • Output devices 14 may include one or more displays, speakers and/or any other suitable output devices. It will be recognized that any suitable number of output devices may be operatively connected to computing device 11 as shown by block 14 .
  • Any applicable input/output (I/O) devices may be connected to computing device 11 as shown by blocks 13 and 14 .
  • NIC network interface card
  • USB universal serial bus
  • Embodiments of the invention may include an article such as a computer or processor non-transitory readable medium, or a computer or processor non-transitory storage medium, such as for example a memory, a disk drive, or a USB flash memory, encoding, including or storing instructions, e.g., computer-executable instructions, which, when executed by a processor or controller, carry out methods disclosed herein.
  • a storage medium such as memory 12
  • computer-executable instructions such as executable code 18
  • controller such as controller 15 .
  • Some embodiments may be provided in a computer program product that may include a non-transitory machine-readable medium, stored thereon instructions, which may be used to program a computer, or other programmable devices, to perform methods as disclosed herein.
  • Embodiments of the invention may include an article such as a computer or processor non-transitory readable medium, or a computer or processor non-transitory storage medium, such as for example a memory, a disk drive, or a USB flash memory, encoding, including or storing instructions, e.g., computer-executable instructions, which when executed by a processor or controller, carry out methods disclosed herein.
  • the storage medium may include, but is not limited to, any type of disk including magneto-optical disks, semiconductor devices such as read-only memories (ROMs), random access memories (RAMs), such as a dynamic RAM (DRAM), erasable programmable read-only memories (EPROMs), flash memories, electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, or any type of media suitable for storing electronic instructions, including programmable storage devices.
  • ROMs read-only memories
  • RAMs random access memories
  • DRAM dynamic RAM
  • EPROMs erasable programmable read-only memories
  • flash memories electrically erasable programmable read-only memories (EEPROMs)
  • magnetic or optical cards or any type of media suitable for storing electronic instructions, including programmable storage devices.
  • a system may include components such as, but not limited to, a plurality of central processing units (CPU) or any other suitable multi-purpose or specific processors or controllers, a plurality of input units, a plurality of output units, a plurality of memory units, and a plurality of storage units.
  • a system may additionally include other suitable hardware components and/or software components.
  • a system may include or may be, for example, a personal computer, a desktop computer, a mobile computer, a laptop computer, a notebook computer, a terminal, a workstation, a server computer, a Personal Digital Assistant (PDA) device, a tablet computer, a network device, or any other suitable computing device.
  • PDA Personal Digital Assistant
  • Non-invasive monitoring device 110 may include one or more one light sources (l 1 , l 2 . . . l n ) 210 for emitting light at at least one predetermined narrow spectral wavelength band onto a living tissue of the subject and one or more light sensors (S 1 , . . . , S n ) 220 .
  • non-invasive monitoring device 110 may include at least one light source 210 and a plurality of light sensors (S 1 , . . . , S n ) 220 .
  • each of the two or more light sensors 220 may correspond to a specific substance in a living tissue of the subject and may be configured to measure a change in a concentration of the specific substances to which sensor 220 corresponds.
  • the distance (d 1 , . . . , d n ) of each of two or more sensors 220 from light source 210 may be determined so that intensity (I 1 , . . . , I n ) of light scattered by each specific substance, may have a maximal signal to noise ratio at the determined distance of the corresponding sensor, as illustrated and discussed with respect to FIG. 2A .
  • the maximal signal to noise ratio may be the ratio between the intensity of light scattered by the specific substance and all other intensities received at the corresponding sensor.
  • the distances (d 1 , . . . , d n ) refers to the Euclidean distance between the geometric center of one active area of a component (e.g., a sensor/alight source) to the geometric center of the other component's active area.
  • the active area of a sensor may include the area at which light photons are being detected and the active area of the light source may include the area from which light photons are emitted.
  • the active area center may be off centered from the geometrical center of the sensors and/or the light sources.
  • non-invasive monitoring device 110 may include a plurality of sources (l 1 , l 2 . . . l n ) 210 and a single light sensor 220 .
  • each of two or more light sources 210 may be located at a different distance from light sensor 220 .
  • each of two or more light sources 210 may correspond to a specific substance in a living tissue of the subject; and one light sensor 220 may be configured to measure a change in a concentration of the specific substances to which light source 220 corresponds.
  • each of the two or more light sources 210 from light sensor 220 may be determined so that intensity (I 1 , . . . , I n ) of light scattered by each specific substance, has a maximal signal to noise ratio at the determined distance of the corresponding light source, as illustrated and discussed with respect to FIG. 2B .
  • one or more light sources 210 may be configured to emit light at one or more narrow spectral wavelength bands.
  • the one or more narrow spectral wavelengths band may include wavelength band having a difference of between 5-100 nm between the upper and the lower wavelengths.
  • the upper and lower wavelengths at each band are between 400-2500 nm.
  • one or more light sources 210 may be or may include a point lights, such as, light emitting diode (LED), VCSEL, semiconductor lasers and the like.
  • one or more light sensors 220 may be configured to detect light at any wavelength, for example, between 400-2500 nm.
  • One or more light sensors 220 may be or may include, for example, photodiodes, such as InGaAs, photodiode and the like.
  • light emitted form one or more light sensors 220 may be in the Infra-Red or near Infra-Red (IR) spectrum.
  • IR Infra-Red
  • IR Infra-Red
  • IR Infra-Red
  • SWIR Short Wave IR
  • imaging may be utilized for measuring physiological signals from the blood of a subject. The SWIR waveband runs from the lower edge of the near IR region at 400 nm up to 2500 nm.
  • non-invasive monitoring device 110 may further include a communication unit 250 .
  • Communication unit 250 may include any communication module that may be configured to wirelessly communicate with external processor (e.g., via Wi-Fi, Bluetooth, near field communication (NFC), etc.), such as computing device 11 , mobile device 120 (illustrated in FIG. 1B ) and the like.
  • non-invasive monitoring device 110 may include computing device 11 .
  • FIG. 1B schematically illustrates a block diagram of non-invasive monitoring system 100 according to some embodiments of the invention. It should be noted that the direction of arrows in FIG. 1B may indicate the direction of information flow.
  • the non-invasive monitoring system 100 may allow continuous and/or repetitive non-invasive monitoring of a subject 10 , using wearable monitoring device 110 .
  • non-invasive monitoring system 100 may allow multi trajectory detection of spectral data in an inhomogeneous medium to extract the changes in chromophore concentration.
  • Non-invasive monitoring system 100 may include at least one monitoring device 110 configured to detect changes in measured physiological signals of subject 10 , and a computerized device 120 (e.g., a processor such as controller 15 of computing device 11 of FIG. 1A in the vicinity of subject 10 and/or a controller in a remote facility such as a medical facility) in communication with at least one monitoring device 110 .
  • Systems and devices 100 , 110 and 120 may be or include components similar to those described in FIG. 1A .
  • the computerized device 120 may be configured to receive data (e.g., wirelessly via communication unit 250 ) corresponding to measured physiological signals from at least one monitoring device 110 .
  • a processor such as controller 15 in FIG.
  • computerized device 120 may determine or calculate at least one physiological signal or value from detected light signals from monitoring device 110 .
  • monitoring device 110 may detect scattered light beams and determine the received intensity to be sent (e.g., wirelessly) to computerized device 120 for further processing to determine at least one physiological signal (e.g., a glucose level may be determined or calculated) for example by calculating a set of equations with multiple variables for multiple wavelengths.
  • computerized device 120 may be or may include, for example, a mobile phone, a tablet, a personal computer, a mobile computer, or any other suitable computing device 120 .
  • system 100 as described herein may include one or more devices such as computerized device 120 .
  • the at least one monitoring device 110 may be removably attachable to the subject's body 10 .
  • the at least one monitoring device 110 may be wearable on a limb of subject 10 and/or on other parts of the subject's body (e.g. on a finger).
  • wearable non-invasive monitoring device 110 may continuously collect data on the physiological signals (e.g., pulse, blood substances levels, etc.) of the subject 10 , as long as monitoring device 110 is worn by (or otherwise attached to) subject 10 , and therefore non-invasive monitoring device 110 may provide ongoing data such that changes in measured physiological signals may be detected.
  • non-invasive monitoring device 110 may collect the data (e.g., and store in a dedicated memory) when non-invasive monitoring device 110 is worn by the subject 10 to be provided to the subject alter one to the subject even when non-invasive monitoring device 110 is not worn by the subject 10 .
  • the monitored data may be transferred from computerized device 120 to wearable monitoring device 110 , and vice versa, via communication unit 250 (e.g., via Wi-Fi, Bluetooth, near field communication (NFC), etc.).
  • communication unit 250 e.g., via Wi-Fi, Bluetooth, near field communication (NFC), etc.
  • a subject 10 wearing monitoring device 110 and also operating a mobile phone may utilize the mobile phone as computerized device 120 in order to transfer data to and from wearable monitoring device 110 via wired and/or wireless communication.
  • wearable monitoring device 110 may include a measuring unit ( 200 in FIGS. 2A and 2B ) with a dedicated controller that may be configured to measure physiological signs of subject 10 , and a power storage unit (e.g. a battery not illustrated).
  • computerized device 120 may include a compatible communication module, a display (e.g. with a user interface), and a processor capable of processing and monitoring the physiological data of subject 10 measured by monitoring device 110 .
  • Computerized device 120 may have, according to some embodiments, a dedicated user interface (e.g. with a dedicated algorithm installed thereon) so as to display real-time measurements to subject 10 .
  • users e.g., the subject, a caregiver and/or physician
  • computerized device 120 may issue an alert (e.g., via display and/or speaker 121 ) upon detection of a change in measured physiological signals exceeding a predetermined threshold.
  • FIGS. 2A and 2B are illustrations of non-invasive monitoring devices for monitoring physiological condition of a subject according to some embodiments of the invention.
  • Device 110 may be attached to skin 20 of subject 10 .
  • the direction of dashed arrows may indicate the direction of the light beams progress.
  • narrow spectral wavelength band e.g., a band of 5-100 nm
  • narrow spectral wavelength band may include wavelength bands 475-480 nm, 500-525 nm, 1000-1010 nm, 1300-1320, 1450-1455, 1800-1900 nm and the like.
  • the light may be reflected/scattered from subcutaneous tissue (e.g. reflected/scattered from blood inside a blood vessel).
  • the light may be reflected/scattered from tissue above a blood vessel and may have different intensities since light reflected/scattered from tissue above a blood vessel may have a weaker reflection/scattering due to higher light absorption in water content.
  • different substances in the blood may have different light absorption/scattering coefficients as function of wavelength. Accordingly, in order to use light scattered/absorbed by a specific substances it is essential to ensure that the collected light (e.g., by a light sensor 220 a , 220 b . . . 220 n ) has maximal signal to noise ratio and has been received from a tissue (e.g., skin layer L i , . . . , L n ) that includes the substance. Since light emitted from one or more light source ( 210 a , 210 b . . .
  • a corresponding distance (d 2 ) between the sensor and the light source may be determined.
  • the scattering from each layer depends from the biochemical composition of the layer (i.e., the substances contained in the layer)
  • two distances between two sensors and a single light source or two light sources and a single sensor may be determined (for example, d 2 and d 3 illustrated in FIG. 2A ).
  • Each of the determined distances may determine such that light scattered from a specific substance in the layer may be received in the sensor (or sensors) at maximal signal to noise ratio at the corresponding sensor.
  • at least 5 sensors and/or at least 5 light sources may be included in device 110 .
  • different wavelength may be used to collect light scattered from different substances. Different wavelength scattered differently from different substances. Accordingly, the wavelengths emitted from one or more sensors may each be determined such that light scattered from a specific substance may be collected by the one or more sensors at maximal signal to noise ratio at the corresponding sensor.
  • computer simulations of the path of light through various layers of a tissue ⁇ L( ⁇ ,t)> have been conducted, using for example, Monte Carlo simulation.
  • the computer simulations were conducted to find optimal distances between light sources and sensors that may ensure light scattered from a specific substance to be collected at maximal signal to noise ratio.
  • the computer simulations may further be use to find the optimal wavelength (or narrow wavelength band) to collect light scattered from a specific substance at maximal signal to noise ratio.
  • measuring unit 200 of devices 110 designed to collect light scattered from specific substances may collect light intensities to be processed by a controller such as controller 15 , computerized device 120 and the like.
  • a set of equations with multiple variables may be created based on the scattered light readings, received in sensors 220 by illuminating a tissue 25 of subject 10 (e.g., a blood vessel) with one or more wavelengths, such that the set of equations may be solved in order to find a change in the concentration of one or more substance in the blood.
  • a tissue 25 of subject 10 e.g., a blood vessel
  • each such equation may correspond to a different substance in the blood and/or correspond to a different wavelength.
  • changes in the light absorption/scattering coefficients may be determined, it may be possible to determine changes in the concentration of a substance in blood (e.g., glucose) by illuminating a tissue with a wavelength corresponding to a known light absorption/scattering coefficient. For example, determining changes in the coefficients of seven different substances by performing measurements with at least seven different wavelengths ( ⁇ 1 , ⁇ 2 . . . ⁇ 7 ) and/or seven different distances (d 1 , d 2 . . . d 7 ).
  • n ⁇ 1 [ ⁇ 1 ⁇ ( ⁇ 1 ) ⁇ ⁇ m ⁇ ( ⁇ 1 ) ⁇ ⁇ ⁇ ⁇ 1 ⁇ ( ⁇ n ) ⁇ ⁇ m ⁇ ( ⁇ n ) ] n ⁇ m ⁇ [ C 1 ⁇ ( t ) ⁇ C m ⁇ ( t ) ] m ⁇ 1 ( 3 )
  • a change of the molar concentration of one of the compounds ⁇ C i (t) may cause a change in the absorption coefficient: ⁇ a
  • n ⁇ 1 [ ⁇ 1 ⁇ ( ⁇ 1 ) ⁇ ⁇ m ⁇ ( ⁇ 1 ) ⁇ ⁇ ⁇ ⁇ 1 ⁇ ( ⁇ n ) ⁇ ⁇ m ⁇ ( ⁇ n ) ] n ⁇ m ⁇ [ ⁇ ⁇ ⁇ C 1 ⁇ ( t ) ⁇ ⁇ ⁇ ⁇ C m ⁇ ( t ) ] m ⁇ 1 ( 5 )
  • the optical density change at the output due to the changes in the molar concentration changes in homogenous medium may be calculated as:
  • n ⁇ 1 L ⁇ [ ⁇ a ⁇ ( ⁇ 1 ) ⁇ ⁇ a ⁇ ( ⁇ n ) ] n ⁇ 1 ( 6 )
  • the scattering coefficient may be calculated as a product of the media scattering coefficient and the media content
  • ⁇ ′ s ( ⁇ , t ) ⁇ s ( ⁇ ) ⁇ C s ( t ) (7)
  • the change in the scattering coefficient due to the changes in the media content may be calculated as:
  • ⁇ ′ s ( ⁇ , t ) ⁇ s ( ⁇ ) ⁇ C s ( t ) (8)
  • the total change in the optical density due to attenuation and scattering in homogenous medium may be calculated as:
  • n ⁇ 1 L ⁇ [ ⁇ a ⁇ ( ⁇ 1 ) + ⁇ s ′ ⁇ ( ⁇ 1 ) ⁇ ⁇ a ⁇ ( ⁇ n ) + ⁇ s ′ ⁇ ( ⁇ 1 ) ] n ⁇ 1 ( 9 )
  • the modified Beer-Lambert law is still applicable to each of the components of the heterogeneous medium, and the total optical density change is the sum of the attenuation and scattering changes of each component.
  • the change in the optical density may be calculated as:
  • the changes in the optical absorption and scattering coefficients and from it the molar concentration changes may be expressed by:
  • measuring unit 200 may include at least one light emitting source 210 (e.g., a point light source), for example, a light emitting diode (LED), Semiconductor Laser, VCSEL, and the like, configured to emit light beams 215 in at least one predetermined narrow spectral wavelength band.
  • the measuring unit 200 may be removably attachable to tissue 20 (e.g., skin) of the subject 10 , so as to emit light beams 215 with the at least one light emitting source 210 onto tissue 20 .
  • measuring unit 200 may be positioned along a sub-tissue (e.g., blood vessel 25 ), for example, on the wrist of the subject 10 .
  • a sub-tissue e.g., blood vessel 25
  • Several layers (L 1 , . . . , L n ) may be identified below tissue 20 of the subject 10 , for example Epidermis layer at 0.3 mm depth, a Dermis layer at 1.5 mm depth and a Subcutaneous layer there below.
  • device 110 may include a wearable housing (not illustrated) for holding at least one light source 210 and two or more light sensors 220 a - 220 n.
  • each of the two or more light sensors 220 a - 220 n may correspond to a specific substance in a living tissue of the subject and is configured to measure a change in a concentration (C 1 . . . C n ) of the specific substances to which the sensor corresponds.
  • light emitted from light source 210 and received at sensors 220 c and 220 d may be proceeded (e.g., by controller 15 ) to determine changes over time in the concentration of the two substances.
  • the distance (d 1 , . . . , d n ) of each of two or more sensors 220 a - 220 n from light source 210 may be determined so that intensity (I 1 , . . . , I n ) of light scattered by each specific substance, may have a maximal signal to noise ratio at the determined distance of the corresponding sensor.
  • the maximal signal to noise ratio is the ratio between the intensity of light scattered by the specific substance and all other intensities received at the corresponding sensor.
  • the distance (d 1 , . . . , d n ) of each of two or more sensors 220 a - 220 n from light source 210 may further determined according to the depth a layer (L 1 , . . . , L n ) of the living tissue in which one or more of the substances is contained.
  • the distance (d 1 , . . . , d n ) of each of two or more sensors 220 a - 220 a from light source 210 may further determined using scattering and absorbing parameters of each substance ( ⁇ a1 . . . ⁇ an ) and ( ⁇ s1 . . . ⁇ sn ).
  • different light sources 210 a - 210 n may emit light indifferent narrow spectral wavelength bands, for instance in order to allow simultaneous measurements of different substances (e.g. glucose, insulin, low density lipoprotein (LDL), very-low density lipoprotein (VLDL) and Albumin) and/or to determine the ratio between measurements of different wavelengths.
  • a single light source 210 may emit light in a plurality of narrow spectral wavelength bands.
  • measurements of different substances e.g. glucose and Albumin
  • each light emitting source 210 or sub-sets (e.g.
  • the number of different narrow spectral wavelength bands may be determined based on the substance to be measured (e.g., two different narrow spectral wavelength bands to measure glucose). For example, a user may select to measure glucose, and thus a first number of narrow spectral wavelength bands is automatically selected by the processor, and for measurement of a different substance a second number of wavelengths is automatically selected (e.g., based on previously carried out calibration).
  • the light emitted from the at least one light emitting source 210 may be, according to some embodiments, in the Infra-Red or near Infra-Red (IR) spectrum.
  • IR Infra-Red
  • SWIR Short Wave IR
  • the SWIR waveband runs from the lower edge of the near IR region at 400 nm up to 2500 nm and may be utilized for inspection of blood and blood components in blood vessels of the subject 10 . It should be noted that if required, the range of the SWIR waveband may be increased.
  • each light emitting source 210 , or sub-set of light emitting sources 210 may emit light in a different time and/or in a different frequency, such that not all light emitting sources 210 emit light simultaneously.
  • the wearable monitoring device 110 may perform optical measuring (e.g. with at least one sensor 220 ) that are non-invasive to gather measurements.
  • measuring unit 200 may include two or more light source 210 a - 210 n , for example a light emitting diodes (LED), configured to emit light beams 215 in at least one predetermined narrow spectral wavelength band.
  • light beams 215 emitted from light sources 210 a - 210 n may be received at at least one sensor 220 .
  • 210 n may correspond to a specific substance in a living tissue of the subject; and light sensor 220 may be configured to measure a change in a concentration (C 1 . . . C n ) of the specific substances to which the light source corresponds.
  • the distance (d 1 , . . . , d n ) of each of two or more light sources 210 a . . . 210 n from light sensor 210 may be determined so that intensity (I 1 , . . . , I n ) of light scattered by each specific substance, has a maximal signal to noise ratio at the determined distance of the corresponding light source.
  • the maximal signal to noise ratio is the ratio between the intensity of light scattered by the specific substance and all other intensities received at the corresponding sensor.
  • the distance (d 1 , . . . , d n ) of each of two or more light sources 210 a . . . 210 n from the light sensor may further be determined according to the depth a layer (L 1 , . . . , L n ) of the living tissue in which one or more of the substances is contained.
  • the distance (d 1 , . . . , d n ) of each of two or more light sources 210 a . . . 210 n from light sensor 220 may further be determined according to the depth a layer (L 1 , . . . , L n ) of the living tissue in which one or more of the substances is contained
  • the measuring unit 200 may be removably attachable to tissue (e.g., skin) 20 of the subject 10 , so as to emit light beams 215 with the at least one light emitting source 210 onto the skin 20 .
  • tissue e.g., skin
  • measuring unit 200 may be positioned along a sub-tissue (e.g., blood vessel 25 ), for example, on the wrist of the subject 10 .
  • Several layers (L 1 , . . . , L n ) may be identified below tissue 20 of the subject 10 as disclosed herein above.
  • device 110 may include a wearable housing (not illustrated) for holding at two or more light sources 210 a - 210 n and at least one light sensors 220 .
  • different light sources 210 a - 210 n may emit light in different narrow spectral wavelength bands, for instance in order to allow simultaneous measurements of different substances, as disclosed herein above.
  • the optical path for each layer L i should be known from the light emitting source 210 to sensors 220 and for each detected wavelength.
  • the path-lengths matrix may be extracted numerically by using Monte-Carlo simulations of the optical trajectory between the light emitting source 210 and sensor(s) 220 .
  • such measurement enables detection of the optical density OD( ⁇ ,t) and calculating ⁇ OD as function of time and wavelengths in multiple trajectories between one or more light emitting sources 210 a - 210 n and one or more sensor(s) 220 a - 220 n.
  • a sensor 220 having an increased distance (compared to other sensors) between a light emitting source 210 and the sensor 220 may detect light beams 215 reflected from subcutaneous tissue within the subject's body 10 .
  • detection of light beams 215 reflected from deeper tissue within the subject's body 10 with known distance (‘d’) between each sensor 220 and at least one light emitting source 210 , may allow detection of light beams 215 reflected from a blood vessel 25 .
  • distance ‘d’ of each sensor may correspond to penetration depth of light beams 215 within the subject's body 10 . It should be noted that deeper subcutaneous tissue may correspond to a blood vessel, for example during calibration light paths passing through blood vessels for each sensor 220 may be determined.
  • At least one light emitting source 210 may emit light beams 215 onto the tissue (e.g., skin) 20 of the subject 10 , to be reflected/scattered from sub-tissue 25 (e.g., by the content of the blood vessel) and then received by at least one sensor 220 .
  • the light beams may be transmitted through the subcutaneous tissue (including the blood vessels therein) of the subject 10 and then received by the sensor 220 .
  • the at least one non-invasive monitoring device 110 may include a controller 230 (e.g., processor or controller 15 as shown in FIG. 1A ), coupled to the measuring unit 200 , and configured to measure and/or analyze physiological signs of the subject 10 .
  • controller 230 may monitor physiological condition of subject 10 based on the detected light beams 215 and also based on at least one predetermined narrow spectral wavelength band, for example by solving a set of equations as described herein
  • the monitoring system 100 may further include positioning correction indicators that are adapted to allow the user to correctly place measuring unit 200 over a blood vessel. For instance, displaying to the user how to move monitoring device 110 to improve positioning of light emitting sources 210 and/or sensors 220 to optimize reflections to the sensor.
  • each light emitting source 210 may be provided with an optical collimator (or reflector) so as to allow directing the light beam emitted by each light source 210 in a specific predefined direction.
  • such measurements may provide an indication for a “health matrix” with continuous glucose monitoring, dehydration monitoring, blood lipids, vitamins, calories, pulse, PWV (Pulse wave velocity) blood pressure, and also an indication of medications, pharmaceuticals and other chemicals in the blood stream of the subject.
  • a “health matrix” with continuous glucose monitoring, dehydration monitoring, blood lipids, vitamins, calories, pulse, PWV (Pulse wave velocity) blood pressure, and also an indication of medications, pharmaceuticals and other chemicals in the blood stream of the subject.
  • PWV Pulse wave velocity
  • the system may continuously or repetitively monitor indication of the changes in glucose levels.
  • the system may perform continuous measurements only upon indication of a significant change such that power is saved and the system operates in “low energy consumption” mode.
  • FIG. 3A shows a flow chart of a method of non-invasive monitoring of physiological measurements of a subject, according to some embodiments of the invention.
  • the method of FIG. 3A may be executed by a controller such as controller 15 , device 120 or controller 230 of non-invasive monitoring device 110 and/or non-invasive monitoring system 100 .
  • at least one light source 210 may be controlled to emit light at least one predetermined narrow spectral wavelengths band.
  • the controller may control at least one light source 210 a - 210 n to emit light at two or more predetermined narrow spectral wavelength bands ( ⁇ 1 , ⁇ 2 . . . ⁇ n ), where each of ⁇ 1 , ⁇ 2 . . . ⁇ n corresponds to the median wavelength of each band.
  • the light may be emitted at a continuous illumination process or at illumination pules or any combination thereof.
  • scattered light intensities I 0 ( ⁇ ) 1 , I 0 ( ⁇ ) 2 . . . . I 0 ( ⁇ ) n received at each of two or more light sensors 220 (S 1 , . . . , S n ) may be measured at an initial time (t 0 ).
  • scattered light intensities I 0 ( ⁇ ) 2 received at sensor S 2 may be measured.
  • the measured light intensity may correspond to the concentration level of substance 2 C 2 (0) at t 0 .
  • scattered light intensities I 0 ( ⁇ ) 2 may be received from layer L 2 .
  • measurements of scattered light intensities may be received at each of the two or more light sensors at the two or more predetermined narrow spectral wavelength bands, at an initial time (t 0 ).
  • scattered light intensities I( ⁇ ,t) 1 , I( ⁇ ,t) 2 . . . I( ⁇ ,t) n received at each of two or more light sensors 220 (S 1 , . . . , S n ) may be measured at at least one consecutive time (t).
  • scattered light intensities I( ⁇ ,t) 2 received at sensor S 2 may be measured.
  • the measured light intensity may correspond to the concentration level of substance 2 C 2 (t) at at least one consecutive time (t).
  • measurements of scattered light intensities may be received at each of the two or more light sensors at the two or more predetermined narrow spectral wavelength bands, at at least one consecutive time (t).
  • the at least one consecutive time (t) may include continuous measurements over time (t) or one or more single measurements received at various times (t 1 , t 2 . . . t p ).
  • a change of a concentration C i (t) in time, of at least one substance in a user's tissue may be determined based on the measured light intensities.
  • the controller may use equation (1)
  • ⁇ ⁇ ⁇ OD ⁇ ( ⁇ , t ) - ln ⁇ ( I ⁇ ( ⁇ , t ) I 0 ⁇ ( ⁇ ) )
  • the controller may than use equation (10) to calculate the change in the scattering and absorbing parameters ⁇ a1 (t)+ ⁇ ′ s1 (t) due to changes in the concentrations of one or more substances.
  • the optical path L( ⁇ ,t) may be known and may depends from the distance d between corresponding light source 210 and light sensor 220 .
  • L( ⁇ ,t) may be estimated to be about 2d.
  • the controller may then use the detected change to determine a change in the scattering and absorbing parameters calculated by equation (10) and to determine a change in the concentration of one or substances, as shown in equations (3)-(8).
  • the controller may determine a physiological condition of subject 10 such as raise in sugar levels in the blood.
  • FIG. 3B shows a flow chart for a method of non-invasive monitoring of physiological measurements of a subject, according to some embodiments of the invention.
  • the method of FIG. 3B may be executed by a controller such as controller 15 , device 120 or controller 230 of non-invasive monitoring device 110 and/or non-invasive monitoring system 100 .
  • a controller such as controller 15 , device 120 or controller 230 of non-invasive monitoring device 110 and/or non-invasive monitoring system 100 .
  • two or more one light sources 210 a - 210 n may be controlled to emit light at least one predetermined narrow spectral wavelengths band.
  • the controller may control two or more light sources 210 a - 210 n to emit light at two or more predetermined narrow spectral wavelength bands ( ⁇ 1 , ⁇ 2 . . . ⁇ n ), where each of ⁇ 1 , ⁇ 2 . . . ⁇ n corresponds to the median wavelength of each band.
  • the light may be emitted at a continuous illumination
  • scattered light intensities I 0 ( ⁇ ) 1 , I 0 ( ⁇ ) 2 . . . . I 0 ( ⁇ ) n received at one light sensors 220 may be measured at an initial time (t 0 ).
  • scattered light intensity I 0 ( ⁇ ) 2 emitted from light source I 2 ( 210 b ) and received at the sensor 220 may be measured.
  • the measured light intensity may correspond to the concentration level of substance 2 C 2 (0) at t 0 .
  • scattered light intensity I 0 ( ⁇ ) 2 may be received from layer L 2 .
  • measurements of scattered light intensities may be received at the sensor at the two or more predetermined narrow spectral wavelength bands, at an initial time (t 0 ).
  • scattered light intensities I( ⁇ ,t) 1 , I( ⁇ ,t) 2 . . . I( ⁇ ,t) n received at light sensor 220 may be measured at at least one consecutive time (t).
  • scattered light intensities I( ⁇ ,t) 2 emitted from light source 210 b received at sensor 210 may be measured.
  • the measured light intensity may correspond to the concentration level of substance 2 C 2 (t) at at least one consecutive time (t).
  • measurements of scattered light intensities may be received the light sensor at the two or more predetermined narrow spectral wavelength bands, at at least one consecutive time (t).
  • the measurements at at least one consecutive time (t) may include continuous measurements over time (t) or one or more single measurements received at various times (t 1 , t 2 . . . t p ).
  • a change of a concentration C i (t) in time, of at least one substance in a user's tissue may be determined based on the measured light intensities.
  • Step 316 of the method of FIG. 3B may be substantially the same as step 306 of the method of FIG. 3A .
  • the method embodiments described herein are not constrained to a particular order in time or chronological sequence. Additionally, some of the described method elements may be skipped, or they may be repeated, during a sequence of operations of a method.

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CN113476043A (zh) * 2021-07-01 2021-10-08 深圳亿杉医疗科技有限公司 一种非侵入式传感装置及检测方法、检测仪

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